在门诊宫腔镜手术中宫颈扩张过程中的程序性镇静和麻醉下,异丙酚和丙泊酚的效力比:一项采用上下顺序分配法的研究。

IF 2.3 3区 医学 Q2 ANESTHESIOLOGY
Lin Jin, Cui-Cui Jiao, Xiao-Ping Chen, Li-Hong Sun, Yu Zhang, Xin-Zhong Cheng, Jin-Zhong Wang, Xiao-Wei Qian
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引用次数: 0

摘要

研究背景异丙酚(HSK3486)是一种新型的 2,6-二取代苯酚衍生物,是一种短效静脉镇静剂,其药效与异丙酚相似,但副作用较少。异丙酚和丙泊酚都常用于门诊宫腔镜手术的镇静。然而,这两种药物的相对效力尚未完全确定:我们的研究旨在探讨环丙酚和异丙酚在门诊宫腔镜扩张术抑制反应中程序性镇静和麻醉的效力比:方法:采用上下顺序分配法计算环丙酚和异丙酚的ED50(50%受试者的有效剂量)值。将 60 名接受日间宫腔镜检查的健康患者随机分为两组,在静脉注射舒芬太尼 0.15ug/kg 2 分钟后,分别静脉注射初始剂量为 0.4 mg/kg 的异丙酚(C 组)或初始剂量为 2 mg/kg 的异丙酚(P 组)。成功反应的定义是在宫颈扩张的情况下患者没有移动。反之,患者出现移动则定义为失败。在反应成功或失败后,相应组的每位随访患者分别减少或增加异丙酚 0.5 mg/kg 或丙泊酚 0.1 mg/kg:结果:异丙酚和丙泊酚在宫腔镜扩张术抑制反应中的ED50估计值分别为0.444 mg/kg (95% CI, 0.385-0.503 mg/kg)和1.985 mg/kg (95% CI, 1.801-2.170 mg/kg)。环丙酚的呼吸抑制、低氧血症和注射疼痛发生率明显低于异丙酚:结论:在门诊宫腔镜手术中,环丙酚和异丙酚预防宫腔镜扩张反应的ED50分别为0.444 mg/kg(95% CI,0.385-0.503 mg/kg)和1.985 mg/kg(95% CI,1.801-2.170 mg/kg)。本研究中观察到的异丙酚与丙泊酚的效力比为 1.0:4.5(95%CI,1:3.9-1:5.1):本研究已在中国临床试验注册中心 http//www.chictr.org.cn/ 注册(注册日期19/11/22 试验编号ChiCTR2200065954)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The potency-ratio of ciprofol and propofol under procedural sedation and anesthesia for outpatient hysteroscopy during cervical dilation: a study using up-and-down sequential allocation method.

Background: Ciprofol(HSK3486) is a novel 2,6-disubstituted phenol derivate, a short-acting intravenous sedative, which has similar efficacy characteristics as propofol with less incidence of side effect. Both ciprofol and propofol are often used in outpatient hysteroscopic surgery for sedation. However, the relative potency of these two drugs has not been fully determined in this context.

Objective: Our study aimed to investigate the potency-ratio of ciprofol and propofol under procedural sedation and anesthesia in restraining reaction of outpatient hysteroscopy dilatation.

Methods: The ED50 (effective dose in 50% of subjects) value for ciprofol and propofol were calculated by Up-and-Down Sequential Allocation Method. 60 healthy patients undergoing daytime hysteroscopy were randomly divided into two groups, which were intravenously injected with ciprofol at an initial dose of 0.4 mg/kg (group C) or propofol at an initial dose of 2 mg/kg (group P) at 2 min after intravenous injection of sufentanil 0.15ug/kg. A successful response is defined as the absence of patient movement in the case of cervical dilation. Conversely, the presence of patient movement is defined as failure. After successful or failed responses, each follow-up patient in the corresponding group was reduced or increased with propofol 0.5 mg/kg or ciprofol 0.1 mg/kg, respectively.

Results: The estimated ED50 value for ciprofol and propofol in restraining reaction of hysteroscopy dilatation was 0.444 mg/kg (95% CI, 0.385-0.503 mg/kg) and 1.985 mg/kg (95% CI, 1.801-2.170 mg/kg), respectively. The incidence of respiratory depression, hypoxemia and injection pain in ciprofol was significantly lower than those in propofol.

Conclusion: The ED50 of ciprofol and propofol in preventing hysteroscopy dilatation reaction was 0.444 mg/kg (95% CI, 0.385-0.503 mg/kg) and 1.985 mg/kg (95% CI, 1.801-2.170 mg/kg) for outpatient hysteroscopy. The potency-ratio of ciprofol and propofol observed in our study was 1.0:4.5(95%CI,1:3.9-1:5.1).

Trial registration: The study was registered at Chinese Clinical Trial Registry http//www.chictr.org.cn/ (Registration date19/11/22 Trial ID ChiCTR2200065954).

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来源期刊
BMC Anesthesiology
BMC Anesthesiology ANESTHESIOLOGY-
CiteScore
3.50
自引率
4.50%
发文量
349
审稿时长
>12 weeks
期刊介绍: BMC Anesthesiology is an open access, peer-reviewed journal that considers articles on all aspects of anesthesiology, critical care, perioperative care and pain management, including clinical and experimental research into anesthetic mechanisms, administration and efficacy, technology and monitoring, and associated economic issues.
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